Modality.AI
Modality.AI is an FDA-listed, HIPAA-compliant AI platform that sells multimodal speech, facial, and motor digital biomarkers to pharmaceutical and biotech sponsors for decentralized clinical trials in neurological and psychiatric conditions.
- Company typePrivate
- Founded2018
- HeadquartersSan Francisco, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Modality.AI does
Modality.AI is a San Francisco-based health technology company founded in 2018 by David Suendermann-Oeft, PhD (CEO) and David Pautler, PhD (CTO) that has built an AI-powered multimodal conversational platform for objective clinical assessment of neurological and psychiatric conditions. The platform uses real-time audiovisual dialog with an AI virtual guide named "Tina" to capture and analyze a patient's speech, facial expressions, and motor function through standard webcam-equipped devices, generating explainable digital biomarkers in minutes without requiring a clinic visit, dedicated hardware, or a clinical rater. The system is listed with the FDA as a Class II medical device, operates on a HIPAA-compliant AI infrastructure, supports GDPR-compliant regional data residency, and is available in more than a dozen languages and dialects.
Modality.AI firmographics
Firmographics- Name
- Modality.AI
- Legal name
- Modality.AI, Inc.
- Website
- https://modality.ai
- Company type
- Private
- Founded year
- 2018
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Modality.AI is an FDA-listed, HIPAA-compliant AI platform that sells multimodal speech, facial, and motor digital biomarkers to pharmaceutical and biotech sponsors for decentralized clinical trials in neurological and psychiatric conditions.
- Ownership category
- akta.pro rank
Modality.AI industry classification
Industry- Product category
- Clinical Trial Digital Biomarker Software
- NAICS
- Computer Systems Design and Related Services (54151)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Conversational AI Platforms (chat/voice bots, orchestration) (HDAAAFAC)
Keywords
Where Modality.AI is headquartered
LocationHeadquarters
- HQ city
- San Francisco
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Modality.AI business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Operations, Infrastructure
Revenue model
- Clinical Trial Assessment Platform (SaaS): Modality provides its multimodal assessment platform to pharma and biotech sponsors for use in regulated clinical trials, supporting both in-clinic and remote administration. The platform supplements or replaces rater-based assessments. Revenue is generated through platform access fees charged to clinical trial sponsors. The company reports commercial traction with an expanding interventional pipeline across ALS, schizophrenia, ADHD, muscular dystrophy, and postoperative neurocognitive disorders.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels8 records
Modality.AI product offering
Product offeringCore offering
Modality.AI provides an AI-powered multimodal assessment platform that uses real-time audiovisual dialog with a virtual guide named Tina to objectively evaluate speech, facial expression, and motor function in patients with neurological and psychiatric conditions. The platform enables both in-clinic and remote administration of clinical trial assessments, allowing pharma and biotech sponsors to supplement or replace rater-based endpoints with automated digital biomarkers. Data is processed in real time on a HIPAA-compliant AI platform, producing explainable, auditable results, and the platform is listed with the FDA as a Class II medical device.
Product overview
Modality.AI offers a unified AI-powered multimodal assessment platform consisting of the Modality Platform and its virtual guide Tina. The platform integrates speech analytics, facial expression analysis via computer vision, and motor function assessment into a single session, enabling remote or in-clinic assessment of neurological and psychiatric conditions without requiring clinic visits, dedicated devices, or clinical raters. Data is processed by a secure, HIPAA-compliant AI platform in real-time with results that are explainable and auditable. The platform is listed with the FDA as a Class II medical device.
Differentiator
Problem solved
Functional benefit
Brands
- Tina: Modality's virtual guide named Tina that leads structured conversations with patients to standardize assessment across sites and languages, reduce site burden, and enable effective decentralized trials.
Products and services
- The Modality Platform
Quantifiable outcome
- Digital speech endpoints were sensitive to short-term disease progression in a Phase 1b ALS trial (VRG50635), detecting functional decline during the 8-week pretreatment run-in period
- +4 more outcomes
Companies that use Modality.AI
Customer profileNamed customers8 records
Segments3 records
Ideal customer profiles2 records
Modality.AI technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability7 records
Feature7 records
Modality.AI partnerships and signals
Strategic signalPartnerships
Nine partnerships are on record, tiered core and minor.
- Ametris (formerly ActiGraph)coreStrategic partnership combining Modality's sensitive speech/visual measures with Ametris's continuous real-world function data from wearable sensors. The goal is to sharpen signal detection in challenging neuro trials by enabling sponsors to better assess whether a therapy is demonstrating measurable efficacy. Joint webinars and co-presentations at ADDS (Ametris Digital Data Summit). Ametris rebranded from ActiGraph in 2025.
- Verge GenomicscoreModality provided speech endpoint assessments for Verge Genomics' VRG50635 Phase 1b ALS clinical trial, demonstrating that digital speech endpoints tracked disease progression and aligned with standard clinical outcomes including ALSFRS-R, respiratory function, and neurofilament biomarkers. Results published in Nature Scientific Reports.
- Target ALScoreTarget ALS and Modality.AI collaborate in a multimodal study of ALS, leveraging the Modality Platform for remote audiovisual assessments in the Target ALS Global Natural History Study (14 people with ALS). Joint presentations at Target ALS Annual Meeting and multiple co-authored publications.
- EverythingALScoreModality partners with EverythingALS on the Speech Project, generating the largest longitudinal audiovisual dataset of people with ALS (143 pALS). Collaborative research presentations and co-authored publications advancing ALS speech biomarker science.
- Precision ALSminorEuropean collaboration for ALS research and clinical trials, with Modality participating in Precision ALS meetings and events in Europe.
- Nathan S. Kline Institute for Psychiatric Research (NKI)coreLong-standing collaboration on speech and visual assessments for schizophrenia, resulting in 17+ peer-reviewed publications. Collaborators include Dr. Jean-Pierre Lindenmayer (Director of the Manhattan Schizophrenia Research Program at NKI).
- Valis BioscienceminorCollaboration with Valis Bioscience on CNS clinical research, with joint presence at the ASCP Annual Meeting. Valis Bioscience co-founders include Christian Yavorsky.
- MGH Institute of Health ProfessionscoreNIH awarded a $2.3 million grant to Modality.AI and the MGH Institute of Health Professions to validate if app-collected data is as effective as expert clinical observations for ALS diagnosis.
- IBM T.J. Watson Research CenterminorIBM Staff Research Scientist Kely Norel presented on deep learning models for assessing speech intelligibility in ALS, building on data collected through EverythingALS's Speech Project in collaboration with Modality.AI.
Scale indicators8 records
Recent moves6 records
Expansion highlights6 records
Modality.AI competitors and assessment
Company assessmentEmerging players
- Altoida: Digital cognitive assessment platform combining AR-based motor and cognitive tasks with AI for early detection of neurological conditions. Adjacent in digital neuro assessment but more consumer/clinical than pharma-trial focused.
Broad incumbents
- Medidata Solutions (Dassault Systèmes): Major eClinical platform serving pharma/biotech with Rave EDC, eCOA, and trial technology infrastructure. Potential incumbent competitor or partner if it expands native digital endpoint / biomarker capabilities.
- Clario (formerly ERT): Large clinical trial technology vendor offering eCOA, imaging, respiratory, and digital endpoint solutions to pharma sponsors. Broader portfolio than Modality, but overlaps in regulated digital endpoints for clinical trials.
Direct peers
- VivoSense: Develops and validates digital endpoints from wearable sensor data for use in regulatory-grade clinical trials. Comparable positioning as a regulated digital endpoint provider for pharma.
- Beacon Biosignals: EEG-based digital biomarker platform for CNS clinical trials, including neurodegenerative and psychiatric indications. Overlaps with Modality on the goal of replacing subjective clinical scales with objective, regulated digital measures.
- Sonde Health: Voice biomarker platform analyzing short voice samples for mental and respiratory health monitoring. Comparable AI-on-speech approach for health-condition detection, though more consumer- and primary-care oriented.
- Aural Analytics: Speech analytics platform that extracts clinical-grade speech biomarkers for neurological conditions. Direct competitor in the speech-as-biomarker niche for pharma trials.
- Cambridge Cognition: Provides digital cognitive and speech-based assessments for CNS clinical trials across indications including Alzheimer's, Parkinson's, and schizophrenia. Closely comparable to Modality in deploying validated digital endpoints for pharma-sponsored studies.
- Cogstate: Digital cognitive testing company supplying computerized assessments (including speech/voice elements) to clinical trials across CNS indications. Comparable go-to-market selling objective digital endpoints into pharma trials.
- Koneksa Health: Digital biomarker company deploying wearable and remote sensor data as clinical trial endpoints in CNS, respiratory, and other indications. Overlaps with Modality on objective, decentralized trial endpoints for pharma sponsors.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights8 records
Customer concentration
Modality.AI social profiles
Digital presenceModality.AI compliance and trust
Trust signalCompliance3 records
Modality.AI financial estimates
Financial estimateRevenue estimate
Valuation estimate
Modality.AI leadership team
Management profileNumber of profiles
Profiles16 records
Modality.AI funding detail
Funding detailFunding overview
Funding rounds7 records
Investors16 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Modality.AI M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Modality.AI
What does Modality.AI do?
Modality.AI provides an AI-powered multimodal assessment platform that uses real-time audiovisual dialog with a virtual guide named Tina to objectively evaluate speech, facial expression, and motor function in patients with neurological and psychiatric conditions. The platform enables both in-clinic and remote administration of clinical trial assessments, allowing pharma and biotech sponsors to supplement or replace rater-based endpoints with automated digital biomarkers. Data is processed in real time on a HIPAA-compliant AI platform, producing explainable, auditable results, and the platform is listed with the FDA as a Class II medical device.
Is Modality.AI a public or private company?
Modality.AI is a private company. It is classified as venture growth investor backed and is currently operating.
When was Modality.AI founded?
Modality.AI was founded in 2018. It employs 11 to 50 people.
Where is Modality.AI based?
Modality.AI is headquartered in San Francisco, United States, in the North America region.
How does Modality.AI make money?
One revenue line is on record: clinical Trial Assessment Platform (SaaS).
Who are Modality.AI's main competitors?
Altoida is listed as an emerging player. Broad incumbents are Medidata Solutions (Dassault Systèmes) and Clario (formerly ERT). Direct peers are VivoSense, Beacon Biosignals, Sonde Health, Aural Analytics, Cambridge Cognition, Cogstate and Koneksa Health.
Does Modality.AI have an API?
No public API is recorded for Modality.AI.
What industry is Modality.AI in?
Modality.AI's product category is Clinical Trial Digital Biomarker Software. Its primary akta.pro industry code is HDAAAFAC, Conversational AI Platforms (chat/voice bots, orchestration). Its NAICS code is 54151 and its SIC code is 7372.